BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:September 2013
End Date:November 2015

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A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime has
shown promise as a treatment of fibromyalgia, but the drug required new formulation
technology for bedtime use. The present trial is designed to assess the safety and efficacy
of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.


Inclusion Criteria:

- Diagnosis of Primary Fibromyalgia (ACR criteria)

- Male or female 18-65 years old

- For patients with major depressive disorders only: clinically stable, no suicidal
risk and stable anti-depressent therapy

- Willing and able to withdraw specific therapies (ask PI)

- Medically acceptable form of contraception (female only)

- Signed informed consent

Exclusion Criteria:

- Arthritis, lupus and other systemic auto-immune diseases

- Regional or persistent pain that could interfere with assessment of fibromyalgia pain

- Bipolar and psychotic disorders

- Increase risk of suicide

- Significant clinical (cardiac, systemic infection, systemic corticosteroid
requirement, drug/alcohol abuse) or laboratory abnormalities.

- Unability to wash-out specific medications (ask PI)

- Known hypersensitivity to cyclobenzaprine

- Others: seizure disorders, sleep apnea, CPAP use, BMI>40
We found this trial at
17
sites
Jackson, Mississippi 39202
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Bellevue, Washington 98007
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Bellevue, WA
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Brooksville, Florida 34601
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Brooksville, FL
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Chicago, Illinois 60634
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Chicago, IL
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Cincinnati, OH
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Columbus, Ohio 43212
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Columbus, OH
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Denver, Colorado 80239
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Denver, CO
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Frederick, Maryland 21702
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Frederick, MD
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Greer, South Carolina 29650
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Greer, SC
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Mechanicsburg, Pennsylvania 17055
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Mechanicsburg, PA
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Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Orlando, Florida 32806
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Orlando, FL
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Sacramento, California 95825
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Sacramento, CA
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Salt Lake City, Utah 84102
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Salt Lake City, UT
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Seattle, Washington 98122
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Seattle, WA
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Worcester, Massachusetts 01610
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Worcester, MA
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